The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
|
It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used in the stomach during a gastrostomy procedure.According to the complainant, during the procedure, it was noticed that the surgical drape was stuck to the seal inside the sterile kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "no injury.".
|